Senior Manager, Medical Coding - FSP

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Summarized Purpose:The Senior Manager, Medical Coding(individual contributor) in Clinical Data Management (CDM) responsible for performing, reviewing and ensuring all medical coding is done accurately and consistently. Assist with the management of third-party vendors such as CROs to ensure the delivery of high-quality coding. Collaborate cross-functionally on coding related matters as appropriate in all therapeutic areas.Here’s What You’ll Do:

Provide independent review of data coded by third parties ensuring consistent coding

Oversee work outsourced to CRO/Vendors through medical coding review and synonym dictionaries review

Participate in the review and maintenance of guidance and training documentation for coding guidelines in accordance with ICH guidelines, internal coding guidelines and dictionary definitions

Communicate issues to medical coding leadership that require decisions including proposal for a solution.

Provide support to other departments concerning dictionary use and coding quality

Collaborate on the creation and maintenance of CDM documents referencing coding related activities

Support and manage MedDRA and WHO Drug Dictionary upversion activities for both internal and external third-party vendor operated studies

Ensure compliance with industry quality standards, regulations, guidelines and procedures

Act as coding SME for project teams by providing cross-functional information on important changes both technically and content related

Here’s What You’ll Bring to the Table:

A degree in nursing, biology or health-related field

English fluency 

8+ years medical coding using MedDRA and WHO Drug dictionaries

8+ years in Pharmaceutical/Biotechnology industry or CRO environment

Knowledge of ICH/GCP guidelines and methodology

Excellent verbal and written communication skills

Detail oriented, ability to multitask with strong prioritization, planning and organization skills

Excellent team player

Proficiency in Microsoft Office Applications

Working knowledge of MedDRA and WHODrug best practice documents

Experience with coding application(s), Veeva and Medidata Rave Coder desirable

Experience with data warehouse tools (ie. Elluminate, CORE)

Good understanding of Clinical Data Management processes and the applicable regulatory requirements

Work EnvironmentThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details.)

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.